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BS EN 12376:1999

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Available format(s)

Hardcopy , PDF

Superseded date

31-08-2013

Superseded by

BS EN ISO 19001:2013

Language(s)

English

Published date

15-07-1999

€140.23
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
    3.1 Information supplied by the manufacturer
    3.2 Label
    3.3 In vitro diagnostic
    3.4 Staining
    3.5 Dye
    3.6 Stain
          3.6.1 Stock solution of stain
    3.7 Chromogenic reagent
    3.8 Fluorochrome
    3.9 Antibody
          3.9.1 Polyclonal antibody
          3.9.2 Monoclonal antibody
    3.10 Nucleic acid probe
    3.11 Lectin
4 Requirements for information supplied by the manufacturer
    4.1 General requirements
          4.1.1 Information supplied by the manufacturer
                  with reagents used for staining in biology
          4.1.2 Product name
          4.1.3 Description of reagent
          4.1.4 Intended use
    4.2 Additional requirements for specific kinds of
          reagents
          4.2.1 Fluorochromes
          4.2.2 Metal salts
          4.2.3 Antibodies
          4.2.4 Nucleic acid probes
Annex A (informative) Examples of information supplied by
the manufacturer with reagents commonly used in biological
staining procedures
A.1 Methyl Green-Pyronin Y stain
A.2 Feulgen-Schiff reaction
A.3 Immunohistochemical demonstration of oestrogen
      receptors
A.4 Flow cytometric demonstration of T-cells
Annex B (informative) Bibliography

Gives the requirements for information supplied by the manufacturer with reagents used in staining in biology. Applicable to producers, suppliers, and vendors of dyes, stains, chromogenic reagents, and other reagents used for staining in biology. Requirements for information supplied by the manufacturer defined in this standard are a prerequisite for achieving comparable and reproducible results in all fields of staining in biology.

Committee
CH/212
DevelopmentNote
Supersedes 96/561615 DC. (08/2005)
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
SN EN 12376 : 1999 Identical
NF EN 12376 : 1999 Identical
NBN EN 12376 : 1999 Identical
NS EN 12376 : 1ED 1999 Identical
UNE-EN 12376:1999 Identical
NEN EN 12376 : 1999 Identical
I.S. EN 12376:1999 Identical
UNI EN 12376 : 2001 Identical
EN 12376:1999 Identical

EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE

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